Pacer with combined defibrillator tailored for bradycardia patients

ABSTRACT

A combination pacer/defibrillator is tailored for bradycardia patients. In one example, its shock-delivery specificity exceeds its sensitivity to shockable ventricular tachyarrhythmias. In another example, its specificity exceeds 95%, or 99%, or even 99.5%. Sensitivity is programmed to a high desired sensitivity value, but only if it can be done without decreasing the specificity below the desired specificity threshold value. This can be conceptualized as “avoiding at all costs” delivering false shocks, even at the expense of failing to deliver a shock to a treatable ventricular tachyarrhythmia. Specificity enhancements include, among other things, inhibiting shock delivery when the patient is breathing or not supine, using multiple channels or a high rate VT/VF detection threshold. The present pacer/defibrillator device could potentially save the lives of bradyarrhythmia patients who are not presently clinically indicated for a defibrillator/pacer, but who have an increased risk of sudden cardiac death due to one or more risk factors.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.10/921,777, filed Aug. 18, 2004, which claims the benefit of priority,under 35 U.S.C. Section 119(e), to Bocek et al. U.S. Provisional PatentApplication Ser. No. 60/600,614, filed Aug. 11, 2004, whichspecifications are herein incorporated by reference.

TECHNICAL FIELD

This patent application pertains generally to implantable cardiac rhythmmanagement devices and more particularly, but not by way of limitation,to a pacer with a combined defibrillator that is tailored forbradyarrhythmia patients.

BACKGROUND

Implantable medical devices include, among other things, cardiac rhythmmanagement (CRM) devices such as pacers, cardioverters, defibrillators,cardiac resynchronization therapy (CRT) devices, as well as combinationdevices that provide more than one of these therapy modalities to asubject. For example, an implantable defibrillator/pacer is typicallyconfigured as an implantable defibrillator with backup pacingcapability. Such devices are intended to serve patients having a historyof previous ventricular or atrial tachyarrhythmia episodes. Ventriculararrhythmias include ventricular tachyarrhythmia (VT) and dangerous andlife-threatening ventricular fibrillation (VF), referred to collectivelyherein as VT/VF. VT/VF is typically treated with antitachyarrhythmiapacing (ATP) therapy or a defibrillation countershock.

A cardiac rhythm management device's detection scheme for a particularcardiac arrhythmias is typically characterized by its “sensitivity” and“specificity.” Sensitivity generally refers to the ability of thedetection scheme to effectively detect an abnormal heart rhythm (e.g.,VT/VF) that the physician desires the cardiac rhythm management deviceto treat. The sensitivity can be expressed as follows:

Sensitivity=True Positives/(True Positives+False Negatives)  (Eq. 1)

Specificity generally refers to the ability of the detection scheme toavoid improperly treating rhythms (e.g., sinus tachycardia) that thephysician determines that the device should not treat. The specificitycan be expressed as follows:

Specificity=True Negatives/(True Negatives+False Positives)  (Eq. 2)

For example, if the rhythm to be detected is VT/VF, then a true positivewould occur when a particular rhythm is VT/VF and the detectionalgorithm correctly declares it as VT/VF. A false negative would occurwhen the rhythm is VT/VF and the detection algorithm erroneouslydeclares it as not VT/VF. A false positive would occur when the rhythmis anything but VT/VF (e.g., normal sinus rhythm (NSR), sinustachycardia, atrial fibrillation, atrial flutter, electrical noise,e.g., due to mypotentials, electromagnetic interference (EMI), a looseset screw for a leadwire, a broken leadwire, etc.) and the detectionalgorithm erroneously declares it as VT/VF. A true negative would occurwhen the rhythm is anything but VT/VF (e.g., normal sinus rhythm (NSR),sinus tachycardia, atrial fibrillation, atrial flutter, electricalnoise, e.g., due to mypotentials, electromagnetic interference (EMI), aloose set screw for a leadwire, a broken leadwire, etc.) and thedetection algorithm correctly declares it as not VT/VF.

Ideally, a cardiac rhythm management device would have both 100%sensitivity and 100% specificity. However, it is well known in the artthat for practical cardiac rhythm management devices, there exists atradeoff between sensitivity and specificity, such that no practicaldetection scheme can obtain the ideal. As discussed above, existingimplantable defibrillator/pacers are typically targeted toward patientswith a history or high risk of life-threatening VT/VF episodes. Becauseof the severe (indeed life-threatening) consequences of failing to treata VF episode, for example, existing defibrillator/pacers are typicallyconfigured to maximize sensitivity to VT/VF. To accomplish this, suchdevices typically sacrifice specificity. That is, they will generallytolerate the delivery of inappropriate countershocks (i.e., a lowerspecificity) if needed to maintain the desired high sensitivity. Thisensures that virtually no VF episode will go untreated. It is true thatmany such defibrillator/pacers go through great lengths to improve thespecificity to avoid inappropriately delivering a painful countershockto the patient. Still, such specificity enhancements typically are asecondary consideration-specificity cannot be increased if doing sowould cause an appreciable number of VF episodes to go untreated—thepotential consequences are too severe, particularly for atachyarrhythmia patient population.

Bradycardia patients, on the other hand, typically receive a pacerwithout defibrillation capability, as presently called for by standardclinical, health insurance, and government reimbursement guidelines.However, a significant number of pacemaker patients die from VF andpolymorphic VT—even if no such previous episodes have been diagnosed.Such patients are ineligible for a defibrillator/pacer device, however,they could benefit from defibrillation therapy. As discussed above,however, existing defibrillator/pacer devices, however, are typicallydesigned as defibrillators with backup pacing capability—they are notintended for bradycardia patients and, moreover, because of the needs ofthe tachycardia patient population for which they are designed, they arenot well suited for bradycardia patients.

In sum, the present inventors have recognized a need in the art forimproved cardiac rhythm management devices having both pacing anddefibrillation therapies.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsdescribe substantially similar components throughout the several views.Like numerals having different letter suffixes represent differentinstances of substantially similar components. The drawings illustrategenerally, by way of example, but not by way of limitation, variousembodiments discussed in the present document.

FIG. 1 is a schematic diagram illustrating generally one example ofportions of a cardiac rhythm management system.

FIG. 2 is a schematic diagram illustrating further details of oneexample of portions of the system.

FIG. 3 illustrates one example of a method of adjusting specificity,either by a physician or other user, or at the factory manufacturing theCRM device.

FIG. 4 illustrates another example of a method of adjusting specificity.

FIG. 5 illustrates one example of using a CRM device.

FIG. 6 illustrates one example of another technique of using the CRMdevice.

FIG. 7 illustrates one example of another technique of using the CRMdevice.

FIG. 8 illustrates one example of another technique of using the CRMdevice.

FIG. 9 illustrates one example of another technique of using the CRMdevice in which further shocks are disabled after delivering adefibrillation shock.

FIG. 10 illustrates one example of another technique of using the CRMdevice in which a specificity or sensitivity is automatically adjustedafter delivering a defibrillation shock.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments, which are also referred to herein as“examples,” are described in sufficient detail to enable those skilledin the art to practice the invention, and it is to be understood thatthe embodiments may be combined, or that other embodiments may beutilized and that structural, logical and electrical changes may be madewithout departing from the scope of the present invention. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present invention is defined by the appended claimsand their equivalents.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one. In this document, the term“or” is used to refer to a nonexclusive or, unless otherwise indicated.Furthermore, all publications, patents, and patent documents referred toin this document are incorporated by reference herein in their entirety,as though individually incorporated by reference. In the event ofinconsistent usages between this documents and those documents soincorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

Introduction

Today, a significant number of pacemaker patients (an estimated 12-30%)die from ventricular fibrillation (VF) and polymorphic ventriculartachyarrhythmias (PVTs). Sudden cardiac death (SCD) survival ratesoutside of the hospital are typically quite low. However, such patientsare typically not indicated for combined defibrillator/pacers.Therefore, according to conventional clinical practice and reimbursementguidelines, they do not receive a device with defibrillation capability,even though such capability could prevent such deaths. Moreover,existing combined defibrillator/pacers are not designed for abradyarrhythmia (pacemaker) population. They are instead designed for atachyarrhythmia-prone patient population, and may therefore beunsuitable for a bradyarrhythmia patient population. For example,devices directed at the tachyarrhythmia-prone population typically havea propensity to deliver “false positive” anti-tachyarrhythmia therapy,such as defibrillation shocks. This has adverse physical andpsychological consequences for bradyarrhythmia patients.

For the bradyarrhythmic/pacemaker patient population that is nototherwise indicated for an implantable cardioverter/defibrillator (ICD),patients with coronary artery disease are particularly at risk of SCD.Such patients with compromised ejection fractions (EFs) are also atincreased risk of SCD. Another risk factor is a prior myocardial infarct(MI) with an EF>30% (such a patient having an EF<30% would typicallyalready be indicated for a combination defibrillator/pacer). Anothertype of at-risk patient would have an EF<30% and would be non-ischemic.Another type of at-risk patient would have a documented history ofnonsustained ventricular tachyarrhythmia (VT). Another risk factor wouldbe a patient that meets the New York Heart Association (NYHA) Class II+classification criteria. Another type of at-risk patient would havemultiple cardiac risk factors (defined as two or more of the following:obesity, smoker, diabetes, hypertension, high cholesterol, or a familyhistory of SCD). In sum, there exist bradyarrhythmic patients who arenot otherwise indicated for an ICD, but who may still obtain somebenefit from antitachyarrhythmia therapy, such as antitachyarrhythmiapacing (ATP) or a defibrillation shock.

EXAMPLES

FIG. 1 is a schematic diagram illustrating generally one example ofportions of a cardiac rhythm management system 100. In this example, thesystem 100 includes an implantable or other cardiac rhythm management(CRM) device 102. The system 100 also typically includes a programmer orother external interface device 104 permitting wireless or othercommunication with the CRM device 102. In the example of FIG. 1, the CRMdevice 102 is implanted in a pectoral region of a patient 106. The CRMdevice 102 in this example includes an electronics unit that is coupledto the patient's heart 108, such as by one or more intravascular orother leads 110. Each such lead 110 typically includes one or moreelectrodes for contacting a desired location within the patient 106,such as for sensing one or more intrinsic electrical heart signals, fordelivering one or more contraction-evoking (e.g., pacing or cardiacresynchronization) stimulations, for delivering one or more shocks forterminating a tachyarrhythmia episode, or for sensing impedance todetect respiration, or the like.

FIG. 2 is a schematic diagram illustrating further details of oneexample of portions of the system 100. In this example, a distal portionof the lead 110 is located in a right ventricle of the heart 108 andincludes one or more electrodes such as a distal tip electrode 200, aslightly more proximal ring electrode 202, and an even slightly moreproximal coil or other shock electrode 204. However, the system 100 mayadditionally or alternatively include other leads or electrodes that maybe located elsewhere in or near the heart 108. The CRM device 102typically includes electronics carried in a hermetically-sealed “can”206. The can 206 typically includes one or more feedthroughs to a header209. The header 209 typically includes one or more receptacles forreceiving a proximal portion of one or more of the leads 110. One orboth of the can 206 or header 209 may also include additionalelectrodes, such as for sensing intrinsic heart or other signals or fordelivering stimulation or other energy to the patient 106.

The electronics unit of CRM device 102 typically includes a heart signalsensing circuit 208 to sense intrinsic electrical heart signals, such asdepolarizations indicative of heart contractions. Such heart signalsalso include information about cardiac arrhythmias, such as VT/VF. Theheart signal sensing circuit 208 typically includes one or more senseamplifier circuits to detect the heart signals, one or more filters foremphasizing depolarizations or other desired information, or forattenuating undesired information. In one example, the heart signalsensing circuit 208 also includes one or more peak or level detectorsfor detecting occurrences of heart depolarizations and providingcorresponding responsive depolarization interrupts to a microprocessoror other controller 210. The controller 210 includes dedicated hardwareor executable instructions to provide its functionality, such as to timethe intervals between like depolarizations to determine a heart rate. Inone example, the controller 210 includes a bradyarrhythmia rate controlmodule 212 to determine whether the heart 108 needs a pacing-levelelectrical stimulation to induce or spatially coordinate a resultingheart contraction. The bradyarrhythmia rate control module 212 deliversone or more control signals to a stimulation circuit 214. In response,the stimulation circuit 214 delivers electrical energy via theelectrodes to the heart 108 to evoke or assist in evoking orcoordinating a responsive heart contraction. The bradyarrhythmia ratecontrol module 212 typically receives information from a rate responsesensor (e.g., accelerometer, minute ventilation, etc.) to indicate thepatient's metabolic need for a particular heart rate and correspondingcardiac output.

In the example of FIG. 1, the controller 210 also includes a VT/VFdetector 218 to determine whether a VT/VF is present and, if so, whethera shock should be delivered to treat the VT/VF. The determination ofwhether VT/VF is present is typically performed by one or more VT/VFdetection modules 220A-M. Each detection module 220 typically includesits own particular criterion, criteria, or technique(s) for determiningwhether VT/VF is present. In one example, the VT/VF detector 218 alsoincludes one or more shock control modules 222A-N. Each shock controlmodule 222 typically includes its own particular criterion, criteria, ortechnique(s) for inhibiting shock delivery even if the VT/VF detectionmodules 220 indicate that a VT/VF is present. If a VT/VF is present, andthe shock control modules 222 do not indicate that a shock should bewithheld, then the VT/VF detector 218 of the controller 210 issues oneor more control signals to a shock circuit 224 instructing it to delivera shock to the heart 108 via the appropriate electrodes.

In one example, CRM device 102 is configured for abradyarrhythmia-indicated patient population that may benefit fromimplantable defibrillation capability, instead of for atachyarrhythmia-prone patient population. In one such example, theparameters controlling VT/VF detection or shock delivery/inhibition arefactory-programmed or otherwise adjusted so that the VT/VF-shockingspecificity of CRM device 102 exceeds its VT/VF detection sensitivity,thereby avoiding false shocks, albeit possibly at the expense of failingto treat a tachyarrhythmia needing treatment. This is a completelydifferent and opposite paradigm than combined pacer/defibrillatorsintended for a tachyarrhythmia-prone patient population, in whichsensitivity typically exceeds specificity in order to avoid failing toshock a treatable tachyarrhythmia. In one example, the parameterscontrolling VT/VF detection or shock delivery/inhibition arefactory-programmed for a target bradyarrhyhmia patient population orotherwise adjusted such that the VT/VF-shocking specificity exceeds 95%,such as by exceeding 99%, or even by exceeding 99.5%. This is difficultto obtain in a practical system because increasing VT/VF-shockingspecificity to such extreme values (e.g., especially above 95%),typically involves sacrificing VT/VF-detection sensitivity to below avalue that would be regarded as acceptable for a tachyarrhythmia-pronepatient population. However, the present inventors have recognized thatincluding antitachyarrhythmia therapy, such as defibrillation shockcapability, in a CRM device 102 that is intended for a bradyarrhythmiapatient population, rather than a tachyarrhythmia-prone patientpopulation, can advantageously reduce or avoid false shocks that wouldbe unacceptable to the bradyarrhythmia patient population. The presentdevice 102 permits VT/VF sensitivity to be less than VT/VF specificity,such as when the specificity exceeds 95%, 99%, or 99.5%. In anotherexample, the specificity exceeds 95%, 99%, or 99.5% without regard tothe sensitivity value.

In one example, the desired specificity is obtained by includingappropriate detection modules 220 or shock control modules 222 and byproperly programming their operative parameters, such as by using theexternal interface 104 at the factory or in the field. In one example,the desired specificity is obtained by factory programming the defaultvalues of such parameters. However, the user is permitted to alter thespecificity, such as by further programming the values of suchparameters away from their default values.

In one example, a detection module 220 includes a rate detector module220A. In one example, the rate detector module 220A deems a VT/VFarrhythmia to be present only if a detected heart rate exceeds a highrate threshold value, such as a high rate threshold value that is in arange between about 200 beats per minute and about 250 beats per minute.In one example, the high rate threshold value is equal to 220 beats perminute. Therefore, in this example, only heart rhythms with a heart ratethat exceeds 220 beats per minute will be deemed a VT/VF arrhythmia bysuch a detection module 220A. The particular high rate threshold valueof the rate detector of detection module 220A can be programmablyadjusted to a higher or lower value to obtain (or to help obtain) thedesired specificity.

In another example, the one or more detection modules 220 include amorphology detection module 220M. In one example, the morphologydetection module 220M compares a morphology of the detected heart signalagainst a template morphology, such as to classify whether a detectedheart rhythm is a VT/VF rhythm that should be shocked. In one example,one or more parameters of such a morphology detection module 220M isadjusted to obtain (or to help obtain) the desired specificity. Anexample of such a parameter would be a correlation coefficient thresholdvalue, where a correlation coefficient between the detected heart rhythmand the template morphology is computed and compared to the thresholdvalue. By decreasing the amount of required correlation between adetected tachyarrhythmia and a template indicative of a non-shockabletachyarrhythmia, a specificity of shock delivery is increased.Alternatively, by increasing the amount of required correlation betweena detected tachyarrhythmia and a template indicative of a shockabletachyarrhythmia, a specificity of shock delivery is increased.

In another example, a sensing control detection module 220B is used tocontrol how ventricular depolarizations are sensed by the heart signalsensing circuit 208, such as to increase the specificity of detecting ashockable ventricular tachyarrhythmia. In one example, the sensingcontrol detection module 220B establishes a higher amplitudelevel-detection threshold on the intrinsic ventricular cardiac signalsensed by the heart signal sensing circuit 208 for declaring thedetection of a ventricular depolarization. For example, a typicalventricular depolarization level-detection threshold is set at about 0.3mV. When the intrinsic cardiac signal exceeds 0.3 mV, a detectedventricular depolarization is declared. However, for the presentincreased shockable VT/VF arrhythmia specificity, the ventriculardepolarization level-detection threshold is instead set between about0.6 mV and 2.5 mV, such as at about 1.1 mV, such that a detectedventricular depolarization is declared only when the intrinsicventricular cardiac signal level exceeds the threshold value (e.g., 1.1mV). This improves noise rejection of spurious myopotentials and othernoise. This increases the specificity of detecting ventriculardepolarizations, which, in turn, increases the specificity of detectingand declaring a shockable VT/VF arrhythmia. In one example, the actualventricular depolarization amplitude level-detection threshold value isestablished by sensing the noise floor of the intrinsic ventricularcardiac signal, and then setting the amplitude level-detection thresholdvalue above the sensed noise floor.

Another example improves specificity by increasing the time durationthat a VT/VF signal must persist at the heart signal sensing circuit 208in order for the VT/VF arrhythmia episode to be declared present. In oneexample, this time duration is increased from a typical value of about 1second (for a defibrillator/pacer intended for the tachyarrhythmiapopulation) to greater than a threshold value that exceeds 15 seconds(e.g., a threshold of 15 seconds, 20 seconds, 25 seconds, 30 seconds,etc.).

In general, there are many types of detection modules 220 that can beused to detect a ventricular arrhythmia such as VT/VF, and the variousoperative parameters of such modules can be programmed to obtain thedesired specificity. Moreover, such detection modules 220 can be usedconjunctively to further increase specificity, such as to obtain aspecificity that exceeds the sensitivity, as discussed above. Thus, therate and morphology detectors discussed above are merely representativeillustrative examples of the types of detection modules 220 that can beused in the present system 100.

The example of FIG. 2 also includes shock control modules 222 to inhibitshock delivery under certain circumstances, even if a VT/VF is detected.This further enhances the specificity of shock delivery of the CRMdevice 102. In one example, a shock control module 222A determineswhether a patient is breathing, and inhibits shock delivery unless it isdetermined that the patient is not breathing. This further enhancesspecificity. In one example, information about whether the patient isbreathing is obtained from a respiration detector circuit 226. Incertain examples, the respiration detector circuit 226 uses thoracic orintracardiac impedance or the like to obtain information about thepatient's breathing; the patient's breathing typically modulates suchimpedances.

In another example, a shock control module 222N determines whether apatient is supine, and inhibits shock delivery unless it determines thatthe patient is supine. This further enhances shock delivery specificity.In one example, information about whether the patient is supine isobtained from an accelerometer-based or other posture detector circuit228.

In yet another example, a shock control module 222 implements anevoked-response detector to determine, in response to a detected VT/VF,whether a delivered pacing pulse evokes a responsive heart contraction.The evoked-response detector shock control module 222 inhibits shockdelivery when such an evoked responsive heart contraction is detectedand permits shock delivery when no such evoked responsive heartcontraction is detected. In one example, the evoked-response detectorshock control module 222 performs this function by issuing a controlsignal that directs the stimulation circuit 214 to issue a pacing pulse.The evoked-response detector shock control module 222 uses the heartsignal sensing circuit 208 to look for a heart contraction that occursin response to the issued pacing pulse. The issued pacing pulse istypically a large energy (i.e., large amplitude or pulsewidth) pacingpulse, which is sometimes referred to as a “safety pace,” and whichwould be expected to capture the heart and result in a responsive heartcontraction. The evoked-response detector shock control module 222further enhances shock delivery specificity.

In another example, a cardiac impedance detector shock control module222 is coupled to a cardiac impedance sensor circuit in the CRM device102 to detect cardiac motion or cardiac output. The cardiac impedancedetector shock control module 222 inhibits shock delivery unless thecardiac motion or cardiac output falls below a corresponding thresholdvalue, thereby indicating a need for delivering a defibrillation shockto resuscitate the patient. In one example, cardiac impedance isdetected by delivering a test current between two intracardiacelectrodes and sensing a responsive voltage across the same (ordifferent) two intracardiac electrodes. The resulting voltage signal isproportional to a cardiac impedance, which is affected and modulated bycardiac wall motion. An absence of wall motion, or a wall motionindicative of VT/VF rather than a well-coordinated ventricularcontraction, provides further evidence that a defibrillation shockshould be delivered. Similarly, a low cardiac output also providesfurther evidence that a defibrillation shock should be delivered. Onemeasure of cardiac output is by the cardiac stroke volume multiplied bythe heart rate, where the stroke volume is indicated by the modulationamplitude of the cardiac impedance signal resulting from ventricularcontractions. By qualifying defibrillation shock delivery with suchmeasurements, defibrillation shock delivery specificity is furtherenhanced.

In another example, a patient activity detector shock control module 222is coupled to an accelerometer sensor circuit in the CRM device 102 todetect patient activity, that is, whether the patient is activelymoving. The patient activity/motion detector shock control module 222inhibits shock delivery when the patient is moving. This furtherenhances defibrillation shock delivery specificity.

In yet another example, the shock control module 222 includes alast-shocked timer to measure an elapsed time since a most recent shockwas delivered, and to withhold shock delivery unless the elapsed timeexceeds an elapsed time threshold value. This further increases shockdelivery specificity, such as by reducing the occurrence of repeatedfalse shocks. As an illustrative example, suppose that the elapsed timethreshold value is set equal to 24 hours. In this example, if a shockhas been delivered during the immediately preceding 24 hours, subsequentshocks are inhibited during the 24 hours after the preceding shock, evenif a VT is detected during such time period. A further exampledistinguishes whether such shocks are being delivered in response to thesame tachyarrhythmia episode, allowing multiple shocks to be deliveredin response to the same tachyarrhythmia episode, but after that episodehas been converted into a non-tachyarrhythmia rhythm, then requiring atime period in excess of the elapsed time threshold value (e.g., 24hours, etc.) to elapse before any subsequent shocks are delivered.

Another example includes a shock control module 222 that automaticallydisables shock delivery after a predetermined number (e.g., one, two,etc.) of shocks have been delivered, or when the predetermined number ofshocks have been delivered to treat a particular tachyarrhythmiaepisode. This reduces the number of false shocks and, therefore, furtherincreases the shock delivery specificity.

Another example includes a shock control module 222 that permits apatient to disable shock delivery, such as after a predetermined number(e.g., one, two, etc.) of shocks have been delivered, or when thepredetermined number of shocks have been delivered to treat a particularVT/VF episode. This reduces the number of false shocks and, therefore,further increases the shock delivery specificity. In one example, thepatient disables shock delivery by placing a magnet near the implantedCRM device 102 to close a reed switch, thereby disabling further shockdelivery. In another example, the patient disables shock delivery byusing a bedside monitor, a portable communication device such as a“Patient Partner” adjunct external device, a programmer, or otherexternal interface 104, which may have more restricted functionalitythan another programmer or other external interface 104 designed for useby a physician or other caregiver. In one example, the CRM device 102only allows the patient to disable further shocks if at least one shockhas been delivered to the patient. In an alternate example, the CRMdevice 102 allows the patient to enable or disable shock deliveryregardless of whether any previous shocks have been delivered. Forexample, the patient may elect to disable shock delivery before engagingin activity resulting in myopotential noise that may trigger falsepositive shock delivery (e.g., painting a house), or during which timereceiving a shock might be dangerous (e.g., standing on a ladder). Thepatient could then later re-enable shock delivery. In a further example,the extent to which a patient can control certain parameters, such asthe ability to disable shock therapy, is in turn controlled by one ormore separate physician-controlled parameters that determine the levelof patient access and control over this or other functions of the CRMdevice 102.

Another example includes a shock control module 222 that includes aduration timer to measure an elapsed time duration since an onset of theVT/VF episode, and to inhibit shock delivery until the elapsed timeduration since the onset of the tachyarrhythmia episode exceeds aduration threshold value that is in a range of between about 10 secondsand about 60 seconds, such as a value of 20 seconds, a value of 30seconds, etc. This further increases the shock delivery specificity ofthe CRM device 102, because a VT/VF episode that does not continue for aperiod of time that exceeds the duration threshold value will not beshocked. In one further example, the CRM device 102 includes a beeper,vibrator, or other device for generating a warning to the patient that adefibrillation shock is about to be delivered. The technique for warningthat a shock is about to be delivered can also be the same as one ormore of the above-described techniques that a shock has already beendelivered, or can be different so that the patient can discern betweenthe incipient-shock warning and the shock-delivered notification. Incertain embodiments, this warning allows the patient to disable theincipient shock delivery, such as by tapping the body (e.g., in apredetermined pattern, such as 3 taps separated by one second each) nearwhere the CRM device 102 is implanted in a manner that can be detectedand recognized by an accelerometer included within the CRM device 102,such that the shock delivery can be disabled.

In another example, the VT/VF detector 218 uses separate first andsecond channels of the heart signal sensing circuit 208 for detecting aVT/VF, thereby further enhancing the shock delivery specificity of theCRM device 102 by reducing the likelihood that noise (e.g., myocardialsignals, electromagnetic interference, etc.) is erroneously sensed as aVT/VF episode. In one such example, the first heart rate signal sensingchannel is coupled to at least one different electrode (e.g., shock coilelectrode 204) than the second heart rate sensing channel (e.g., coupledto tip electrode 200). For example, where the detection module 220includes a high rate detection module 220A, as discussed above, in oneexample the detected heart rate must exceed the high rate threshold(e.g., 220 beats per minute) on each of the first and second heart ratesensing channels.

In one example, one or more parameters of the one or more detectionmodules 220 or of the one or more shock control modules 222 or otherportion(s) of the CRM device 102 are programmed to obtain a desiredcomposite specificity (for example, a specificity that exceeds thesensitivity, or a specificity that exceeds 95%, 99%, and even 99.5%). Ina further example, such parameters are also then programmed to provide ahigh sensitivity—but not at the expense of reducing the specificitybelow the target value to which it was programmed. In one example, thedesired specificity is obtained by factory-programming such parametersto obtain an expected specificity as determined by previous testing,such as on an appropriate target patient population. In another example,these parameters are user programmable to obtain the desiredspecificity. In one example, the external interface 104 includes adisplay 112 that lists or otherwise displays one or more combinations ofsuch parameters, along with an indication of the expected or projectedspecificity or sensitivity for that combination, such as can bedetermined from or estimated from prior testing on the appropriatetarget patient population. In a further example, the external interface104 also includes a processor 114 coupled to the display by a node/bus116. Among other things, the processor 114 controls the content thatappears on the display 112. In one example, the external interface 104receives user input specifying a target specificity, and the processor114 automatically adjusts values of one or more of the parameters toobtain the target specificity by using stored specificity informationcorresponding to various parameter values or combinations of parametervalues.

Although FIG. 2 has been illustrated above as separating VT/VF detectionmodules from shock control modules that inhibit shock delivery even if aVT/VF is detected, this separation into distinct functions is merelyprovided to help the reader's conceptualization of the present systems,devices, and methods. It should be understood that detection andinhibition can be blended. Moreover, a particular specificity isobtainable not merely from detection modules or shock control modules,but also or alternatively by implementation or adjustment of otherportions of the CRM device 102. In one such illustrative example, thedepolarization amplitude threshold of heart signal sensing circuit 208is increased to increase the antitachyarrhythmia therapy deliveryspecificity. In another example, the device includes or adjusts anelectromagnetic interference (EMI) mitigation circuit to improvespecificity by reducing false positive VT/VF detection resulting fromEMI.

In a further example, the CRM device 102 is configured to notify thepatient that a shock has been delivered—since it is possible that thepatient may not be aware of that event. As an illustrative example, thepatient may be sleeping when a shockable VT/VF is detected, the shockmay be delivered during sleep or unconsciousness, and the patient mayhave no memory of the shock later. Such notification that a shock hasbeen delivered is particularly important, for example, for a patientwith no previous history of VT/VF symptoms. For such a patient, thedelivery of the high specificity shock to terminate a VT/VF episode willtypically indicate that the patients disease symptoms have justdramatically changed, such that immediate consultation with a physicianmay be appropriate. There are a number of ways that such a notificationcan be provided. In one example, the CRM device 102 includes a beeper orother speaker or a vibrator to produce a distinctive pattern thatcontinuously or intermittently notifies the patient that a shock hasbeen delivered, such that a physician should be consulted as soon aspossible. In another example, the CRM device 102 includes a telemetrycircuit that communicates with an external device, such as a bedsidemonitor device or a “Partner” external device that is adjunct to theimplantable CRM device 102, a repeater connected to a communicationsnetwork for communication to an Advanced Patient Management (APM)computer system for managing various CRM devices 102 in differentpatients. The external device can notify the patient directly (e.g.,with a visual or audible indicator), or indirectly (such as by aprerecorded telephone message or a telephone call from a customerrelations representative, an e-mail message, etc.). The external devicecan also notify the patient's doctor that a shock has been delivered.Other examples of notification could include delivering intermittent orother high rate pacing or a low-energy (“tickle”) shock to the patientto warn the patient that a high energy defibrillation shock has beendelivered, or by appropriately adjusting other perceptible therapy thatis safe to deliver to the patient and different enough from thepatient's ordinary therapy such that it can be recognized by the patientas a warning that the shock has been delivered.

FIG. 3 illustrates one example of a method of adjusting specificity,either by a physician or other user, or at the factory manufacturing theCRM device. At 300, parameter values associated with the one or moredetection modules 220 or the one or more shock control modules 222 orother modules are displayed, such as on a computer monitor or otherdisplay 112, along with the expected specificity yielded by suchcombination of parameters. At 302, if the specificity is not greaterthan or equal to a target value, then one or more of the parametervalues is reprogrammed or otherwise adjusted at 304, and process flowreturns to 300 to display the new parameter values and expectedspecificity. At 302, if the specificity is greater than or equal to thetarget value, then the process is deemed complete at 306.

FIG. 4 illustrates another example of a method of adjusting specificity,either by a physician or other user, or at the factory manufacturing theCRM device. At 400, parameter values associated with one or moredetection modules 220 or the one or more shock control modules 222 orother modules are displayed, such as on a computer monitor or otherdisplay 112, along with the expected specificity and sensitivity yieldedby such combination of parameters. At 402, if the specificity does notexceed the sensitivity, then one or more of the parameter values isreprogrammed or otherwise adjusted at 404 and process flow returns to400 to display the new parameter values and expected sensitivity andspecificity. Otherwise, at 402, if the specificity exceeds thesensitivity, then the process is deemed complete at 406.

After the parameters are appropriately adjusted to obtain the desiredspecificity, as discussed above, the CRM device 102 is used. One exampleof using the CRM device 102 is illustrated in FIG. 5. At 500, at leastone intrinsic electrical heart signal is detected from a heart of apatient. In one example, this is a ventricular signal that, at leastduring normal ventricular rhythms, includes QRS complexes indicative ofventricular depolarizations. Such ventricular signals also includediscernable characteristics indicative of ventricular tachyarrhythmias,such as a ventricular fibrillation or polymorphic ventriculartachyarrhythmia (PVT) episode to be treated by an electrical shock tothe heart. At 502, one or more stimulations are delivered to the heart,if needed to treat a bradyarrhythmia or as part of a cardiacresynchronization therapy (CRT) that is intended to improve spatialcoordination of the heart contraction to improve cardiac output. Anysuch stimulations are delivered at an energy level (e.g., at apacing-type energy level) that is appropriate to evoke or assist inevoking a responsive heart contraction. At 504, a determination is madeof whether a shockable arrhythmia is detected. Examples of a shockablearrhythmia include ventricular fibrillation (VF) or a shockablepolymorphic ventricular tachycardia. This detection is performed using atechnique having a specificity and a sensitivity, such as from aparticular combination of parameters used in detecting the shockablearrhythmia and in delivering/inhibiting shock therapy. In one example,the specificity exceeds the sensitivity. In one example, thedetermination of whether a shockable arrhythmia exists includes (or,alternatively, consists of) determining whether a ventricular heart rateexceeds a high rate threshold value, such as 220 beats per minute. At504, if a shockable arrhythmia is detected then, at 506, a shock isdelivered in response to the VT/VF, either alone or in combination withone or more other triggers. The shock is intended to terminate the VT/VFsuch that the heart reverts back to a non-tachyarrhythmic rhythm.Process flow then returns to 500. At 504, if a shockable arrhythmia isnot detected, then process flow returns to 500.

FIG. 6 illustrates one example of another technique of using the CRMdevice 102. This example includes acts at 500, 502, and 504 that aresimilar to those described above with respect to FIG. 5. If a shockablearrhythmia is detected at 504, then one or more determinations is madeas to whether to inhibit the shock delivery. For example, at 600, it isdetermined whether the patient is breathing. If the patient isbreathing, then a shock is withheld, at 604, and process flow returns to500. At 600, if the patient is not breathing, then zero or more furtherdeterminations are made as to whether to inhibit the shock delivery. Forexample, at 606, it is determined whether the patient is moving (forexample, by comparing an accelerometer output level to a thresholdvalue). If the patient is moving, then a shock is withheld, at 604, andprocess flow returns to 500. At 606, if the patient is not moving, thenzero or more further determinations are made as to whether to inhibitthe shock delivery. For example, at 608, it is determined whether thepatient's cardiac output exceeds a threshold value (for example, byusing a cardiac impedance sensor). At 608, if the patient's cardiacoutput exceeds the threshold value, then a shock is withheld at 604, andprocess flow returns to 500. At 608, if the patient's cardiac outputdoes not exceed the threshold value, then zero or more furtherdeterminations are made as to whether to inhibit the shock delivery. Forexample, at 610, it is determined whether cardiac wall motion exceeds athreshold value. At 610, if the cardiac wall motion exceeds thethreshold value, then a shock is withheld at 604, and process flowreturns to 500. At 610, if the cardiac wall motion does not exceed thethreshold value, then zero or more further determinations are made as towhether to inhibit the shock delivery. In the example of FIG. 6, afterall shock inhibition decisions indicate that shock delivery is not to beinhibited at 604, then at 612, a defibrillation shock is delivered.Process flow then returns to 500.

FIG. 7 illustrates one example of another technique of using the CRMdevice 102. This example includes acts at 500, 502, and 504 that aresimilar to those described above with respect to FIG. 5. If a shockablearrhythmia is detected at 504, then at 700, it is determined whether thepatient is supine. If the patient is supine, then a shock is deliveredat 702, and process flow then returns to 500. Otherwise the shock iswithheld at 704 and process flow returns to 500. In the example of FIG.7, one or more other shock inhibition determinations can be appliedconjunctively with the determination of whether the patient is supine,such as described above with respect to FIG. 6, for example. Thisfurther enhances the specificity of the shock delivery.

FIG. 8 illustrates one example of another technique of using the CRMdevice 102. This example includes acts at 500, 502, and 504 that aresimilar to those described above with respect to FIG. 5. If a shockablearrhythmia is detected at 504, then at 800, it is determined whether anelapsed time since a most recent shock exceeds a threshold value (e.g.,24 hours). If so, a shock is delivered at 802, provided that it is notinhibited by another conjunctive shock control module 222, and processflow then returns to 500. Otherwise, the shock is withheld at 804, andprocess flow returns to 500. In the example of FIG. 8, one or more othershock inhibition determinations can be applied conjunctively with thedetermination at 804, such as described above with respect to FIG. 6,for example. This further enhances the specificity of the shockdelivery.

FIG. 9 illustrates one example of another technique of using the CRMdevice 102. This example includes acts at 500, 502, and 504 that aresimilar to those described above with respect to FIG. 5. If a shockablearrhythmia is detected at 504, then at 900 it is determined whethershocks are enabled. At 900, if shocks are enabled, then a shock isdelivered at 902, otherwise process flow returns to 500. After a shockis delivered at 902, it is determined at 904 whether enough shocks havebeen delivered to treat that arrhythmia episode. At 904, if enoughshocks have been delivered to treat that tachyarrhythmia episode, thenfurther shocks are automatically disabled at 906. Further shock deliveryis then inhibited until shocking is re-enabled by a physician. At 904,if enough shocks have not been delivered to treat that tachyarrhythmiaepisode (such as when a predetermined number of shocks has not beenreached), then process flow returns to 504.

In an alternative example, instead of the device 102 automaticallydisabling shock delivery at 906, the patient is permitted to disableshock delivery at 906. In one example, the patient is only permitted todisable shock delivery if at least one shock has been delivered to treatat least one tachyarrhythmia episode. In a further example, the patientis also permitted to re-enable shock delivery, if desired.

FIG. 10 illustrates one example of another technique of using the CRMdevice 102. This example includes acts at 500, 502, and 504 that aresimilar to those described above with respect to FIG. 5. If a shockablearrhythmia is detected at 504, then at 1000, the CRM device 102determines whether the shock should be inhibited, such as by using oneof the specificity enhancements described above. If this determinationindicates that the shock should be inhibited for that particulardetected arrhythmia, then a first shock inhibit flag is set. If thisdetermination indicates that the shock should be inhibited for thatparticular detected arrhythmia as well as other subsequently detectedarrhythmias (such as where shock delivery has been disabled by thepatient or automatically by the CRM device 102, for example), then asecond shock inhibit flag is set. If either shock inhibit flag is set,then process flow returns to 500. Otherwise, at 1002, one or more shocksis delivered to treat that tachyarrhythmia episode. After apredetermined number (e.g., 1, 2, etc.) of shocks is delivered at 1002,then, in one example, a patient is permitted to disable further shocks(or alternatively, the CRM device 102 automatically disables furthershocks) by setting the second shock inhibit flag. At 1004, if thepatient has disabled further shocks, then process flow returns to 500with the second shock inhibit flag set to inhibit further shocks at1000. Otherwise, at 1006, in one example, the CRM device 1002automatically adjusts the specificity and sensitivity appropriate for apatient with a documented history of tachyarrhythmia (e.g., adjustingsensitivity>specificity), since the patient has now received at leastone defibrillation shock in response to a detected tachyarrhythmiaepisode. In one example, the CRM device 102 also notifies the patient ordoctor about the delivery of the defibrillation shock and the resultingchange in status and in specificity or sensitivity. Then, process flowreturns to 500.

The above description has particularly emphasized defibrillation shockas an antitachyarrhythmia therapy, at least part because the importanceof specificity is perhaps easiest to understand in that context.However, the present document also envisions antitachyarrhythmia pacing(ATP) therapy or other antitachyarrhythmia therapy being deliveredinstead of or in addition to defibrillation shock therapy. For example,incorporating defibrillation shock therapy into a bradyarrhythmiatherapy device opens up new possibilities for using ATP pacing for sucha patient population, because such ATP pacing is fairly effective atterminating tachyarrhythmias, but presents a finite risk of inducing VF.Where the bradyarrhythmia therapy device includes defibrillation shocktherapy, the risk of using ATP pacing to terminate a tachyarrhythmia isoffset by the availability of a defibrillation shock.

Although the above techniques have been particularly described withrespect to implementing antitachyarrhythmia therapy in a device that istailored for the bradyarrhythmia population, certain of thesespecificity enhancements or other techniques will also be useful in animplantable cardioverter/defibrillator device that is intended for atachyarrhythmia population, such as for improving shock deliveryspecificity. Likewise, certain of these specificity enhancements orother techniques will be useful in a “leadless” or other subcutaneouslyimplantable cardioverter/defibrillator device, which may not include anypacing capability. Because such leadless ICDs typically do not includean electrode in close proximity to the heart, they typically must relyon “far-field” sensing, which increases the risk of false positive VT/VFdetection, making the above-described specificity enhancementsparticularly valuable for such leadless ICDs.

Moreover, although the above description has emphasized techniques fortailoring a pacer/defibrillator for a bradyarrhythmia population, theyare not limited to specially designing a pacer/defibrillator device fora bradyarrhythmia population. Instead, such techniques are also intendedto be useful for retrofitting an existing defibrillator/pacer that wasoriginally intended for a tachyarrhythmia population to tailor thatexisting defibrillator/pacer for use with a bradyarrhythmia patient orbradyarrhythmia patient population. In one such illustrative example, anexisting multiple rate zone or other defibrillator/pacer is reprogrammedto use a single rate zone that declares a VT/VF if a detected heart rateexceeds a threshold value, such as a threshold value that is greaterthan or equal to 200 beats per minute (e.g., 210 bpm, 220 bpm, 230 bpm,240 bpm, etc.). A defibrillation shock or other antitachyarrhythmiatherapy is delivered if a detected VT/VF is declared.

Furthermore, although the above description has describedantitachyarrhythmia therapy in terms of sensitivity and specificity,other alternative measures may also be useful. For example, thespecificity described by Eq. 2 may present a practical difficultybecause the occurrence of a true negative may be a difficultdetermination. Therefore, in one example, a “positive predictivity”metric is used as a surrogate for the above-described balance betweenspecificity and sensitivity. The positive predictivity is described byEq. 3:

Positive Predictivity=True Positives/(True Positives+FalsePositives)  Eq. 3

The positive predictivity described by Eq. 3 has the practical advantageof being defined without regard to the occurrence of a true negative. Atypical defibrillator/pacer that is designed for a tachyarrhythmiapopulation, but that is used in a bradyarrhythmia patient population,will have a ratio of true positives to false positives of about 1:1. Bycontrast, in one example, the pacer/defibrillator of the present systemis specifically tailored for the bradyarrhythmia population byconfiguring its ratio of true positives to false positives to equal orexceed about 3:1, such that the positive predictivity exceeds 75%. Insome examples, the positive predictivity even exceeds 90%.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. Many other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the inventionshould, therefore, be determined with reference to the appended claims,along with the full scope of equivalents to which such claims areentitled. In the appended claims, the terms “including” and “in which”are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Moreover, in the following claims, the terms“first,” “second,” and “third,” etc. are used merely as labels, and arenot intended to impose numerical requirements on their objects.

1. An apparatus comprising: an implantable cardiac rhythm managementdevice, the cardiac rhythm management device comprising: a heart signalsensing circuit to sense intrinsic electrical heart signals from a heartof a patient; a ventricular tachyarrhythmia/fibrillation detectorcircuit, operatively coupled to the heart signal sensing circuit, theventricular tachyarrhythmia/fibrillation detector circuit operable todetect a ventricular tachyarrhythmia/fibrillation, wherein theventricular tachyarrhythmia/fibrillation detector circuit has asensitivity and a specificity, and wherein the ventriculartachyarrhythmia/fibrillation detector circuit is configured such thatthe specificity exceeds the sensitivity; a defibrillation shock circuit,coupled to the ventricular tachyarrhythmia/fibrillation detectorcircuit, the defibrillation shock circuit configured to deliver adefibrillation shock in response to the detected ventriculartachyarrhythmia/fibrillation; and a stimulation circuit, coupled to theheart signal sensing circuit, the stimulation circuit configured todeliver to the heart a stimulation at an energy level appropriate toevoke or assist in evoking a responsive heart contraction.